Status:
TERMINATED
Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD
Lead Sponsor:
Nobel Biocare
Conditions:
Partial Edentulism
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70 years, provided ...
Eligibility Criteria
Inclusion
- The subject must be at least 18 (or age of consent) and less than 70 at the time of inclusion.
- The subject is healthy and compliant with good oral hygiene.
- The subject is in need of at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.
- The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- Obtained informed consent from the subject.
- No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
- Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
- The subject is available for the 5-year term of the investigation.
Exclusion
- The subject is not able to give her/his informed consent to participate.
- Alcohol or drug abuse as noted in patient records or in patient history.
- Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
- An existing condition where acceptable retention of the restoration is impossible to attain
- Mobility of the tooth to be restored.
- Pathologic pocket formation of 4 mm or greater around the tooth to be restored.
- Severe bruxism or other destructive habits.
- Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth).
- Health conditions, which do not permit the restorative procedure.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02188212
Start Date
March 1 2010
End Date
July 1 2014
Last Update
March 3 2021
Active Locations (1)
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1
Universitätsklinikum Aachen
Aachen, Germany, 52074